6bcd35f5-18ea-4fc8-84cd-06db73f38a1e

SPL v5
SPL
SPL Set ID 6bcd35f5-18ea-4fc8-84cd-06db73f38a1e
Route
oral
Published
Effective Date 2022-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.24 g)
Inactive Ingredients
water xylitol c12-20 alkyl glucoside polyoxyl 40 hydrogenated castor oil stevia rebaudiuna leaf sodium lauroyl sarcosinate povidone k30 silver calcium citrate potassium sorbate citric acid monohydrate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-12-01

Purpose

Anticavity

Description

Sodium Fluoride 0.24%


Medication Information

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing

is accidentally swallowed, get medical help or contact a Poison Control Central right away.

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably

after each meal or at least twice per day, or as directed by a dentist or physician.

● Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

● Shake before use.

● Squirt two times into your mouth and start brushing.

● Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: consult a dentist or physician.

Inactive Ingredients

Aqua, Xylitol, Alkyl Glucoside, Peg-40 Hydrogenated Caster Oil, Stevia Rebaudiana Extract, LS 95, PVP-K30, Peppermint Flavor, Nano Silver,

Calcium Citrate, Potassium Sorbate, Citric Acid

Description

Sodium Fluoride 0.24%

Section 50565-1

Product Label

● Questions?

●   Phone Support: 1-888-468-7404

Active Ingredient

Sodium Fluoride 0.24%


Structured Label Content

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing

is accidentally swallowed, get medical help or contact a Poison Control Central right away.

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably

after each meal or at least twice per day, or as directed by a dentist or physician.

● Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

● Shake before use.

● Squirt two times into your mouth and start brushing.

● Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: consult a dentist or physician.

Inactive Ingredients

Aqua, Xylitol, Alkyl Glucoside, Peg-40 Hydrogenated Caster Oil, Stevia Rebaudiana Extract, LS 95, PVP-K30, Peppermint Flavor, Nano Silver,

Calcium Citrate, Potassium Sorbate, Citric Acid

Section 50565-1 (50565-1)

Product Label (Product label)

● Questions?

●   Phone Support: 1-888-468-7404

Active Ingredient

Sodium Fluoride 0.24%


Advanced Ingredient Data


Raw Label Data

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